NovatoRecruiter Since 2001
the smart solution for Novato jobs

Sr. Quality Assurance Specialist

Company: Bayside Solutions
Location: Novato
Posted on: January 16, 2022

Job Description:

Bayside Solutions is seeking a Sr. Quality Assurance Specialist to be part of our client's team in Novato, CA . This is an opportunity to work for an organization that develops and markets new drug development for rare diseases caused by genetic abnormalities.

Sr. Quality Assurance Specialist

Contract Length: 1 year

Location: Novato, CA

***Role is currently remote, but will need to be able to come onsite once restrictions lift***
Summary of Responsibilities:
Ensure adherence to company policies/procedures, regulatory licenses or clinical trial applications, applicable Quality and Technical agreements, industry standards, and GMP regulations.?
Support development of commercial and clinical GMP systems.
Assist with driving implementation of a science and risk-based Quality Culture throughout the External Quality team.
Provide quality oversight of external commercial and clinical CMO's for those products and services as licensed by the HPRA and FDA, as supervisory authority.
Provide quality oversight of one or more portions of operations including, but not limited to; review of documentation, change requests, batch record and associated documentation review, deviation/CAPA review, and lot release.?This involves coordination with other groups such as supply chain, CMO, CMO Pack Ops, etc.
Work directly with CMO, Supply Chain, Clinical Manufacturing, QC, and Regulatory Affairs to ensure lots are released to meet supply requirements.
Conduct lot assessments for product complaints.
Assist with QA decision, direction, and leadership in assigned interdepartmental meetings.
Assist with regulatory inspections.
Implement continuous process improvements.
Other duties as assigned.

Summary of Qualifications:
3-5 years' experience with degree
Knowledge with some CMO, Supply Chain, Clinical Manufacturing, QC, and Regulatory Affairs regulations and policies

Job Requirements:
3-5 years' experience with degree Knowledge with some CMO, Supply Chain, Clinical Manufacturing, QC, and Regulatory Affairs regulations and policies

Keywords: Bayside Solutions, Novato , Sr. Quality Assurance Specialist, Other , Novato, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Novato RSS job feeds